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DAY L

Dosage form: lotion
Ingredients: AVOBENZONE 25mg in 1mL, OCTINOXATE 75mg in 1mL, OCTISALATE 40mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-122

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CONSUMER LABELING

Active ingredients:

AVOBENZONE 2.5 %

OCTINOXATE 7.5 %

OCTISALATE 4.0 %

 

Purpose: Sunscreen

Keep out of children’s reach.

A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. 

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides moderate protection against sunburn.

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.





Directions

Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed.
Children under 6 months of age: ask a doctor.

Inactive ingredients:  aqua/water/eau, acer saccharum (maple isolate), butylene glycol, hydrolyzed collagen, hydrolyzed elastin, octocrylene, cetyl alcohol, glyceryl stearate SE, ceteareth-12, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, coco- caprylate/caprate, polysorbate-80, carbomer, tocopheryl acetate, retinyl palmitate, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance

B. KAMINS

DAY LOTION SPF15

50mL / 1.7 fl.oz

DIN 02248016


DAY L 
avobenzone octisalate octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-122
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE25 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ACER SACCHARUM SAP 
BUTYLENE GLYCOL 
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) 
OCTOCRYLENE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
CETEARETH-12 
CYCLOMETHICONE 4 
CYCLOMETHICONE 5 
POLYETHYLENE GLYCOLS 
DIMETHICONE 
COCO-CAPRYLATE 
POLYSORBATE 80 
CARBOMER 934 
ALPHA-TOCOPHEROL ACETATE 
VITAMIN A PALMITATE 
SODIUM HYDROXIDE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
SORBIC ACID 
Packaging
#Item CodePackage Description
1NDC:63550-122-0350 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/07/2012
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIOperations
Kamins Dermatologics Inc.254050784manufacture, pack, label

Revised: 03/2012
Document Id: e847604f-6169-4e63-9a46-a71458b44cb2
Set id: a70592cb-b4d4-4e65-9281-6b0a0461a2ba
Version: 2
Effective Time: 20120307
 
Kamins Dermatologics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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